EN ISO 22118:2011
(Main)Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection and quantification of food-borne pathogens - Performance characteristics (ISO 22118:2011)
Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection and quantification of food-borne pathogens - Performance characteristics (ISO 22118:2011)
ISO 22118:2010 specifies minimum requirements of performance characteristics for the detection of nucleic acid sequences (DNA or RNA) by molecular methods. ISO 22118:2010 applies to the detection of food-borne pathogens in foodstuffs and isolates obtained from them using molecular detection methods based on the polymerase chain reaction (PCR).
ISO 22118:2010 is also applicable, for example, to the detection of food-borne pathogens in environmental samples and in animal feeding stuffs.
Mikrobiologie von Lebensmitteln und Futtermitteln - Polymerase-Kettenreaktion (PCR) zum Nachweis und zur quantitativen Bestimmung von pathogenen Mikroorganismen in Lebensmitteln - Leistungsmerkmale (ISO 22118:2011)
Diese Internationale Norm legt die Mindestanforderungen an die Leistungsmerkmale für den Nachweis von
Nukleinsäuresequenzen (DNS oder RNS) mittels molekularer (Nachweis-)Verfahren fest. Diese Internationale
Norm gilt für den Nachweis von pathogenen Mikroorganismen in Lebensmitteln und aus Lebensmitteln
gewonnenen Isolaten unter Anwendung von molekularen Nachweisverfahren auf der Grundlage der
Polymerase-Kettenreaktion (PCR).
Diese Internationale Norm kann zum Beispiel auch für den Nachweis von über Nahrungsmittel übertragenen
pathogenen Mikroorganismen in Umweltproben oder in Futtermitteln angewendet werden.
ANMERKUNG Auf Grund des schnellen Fortschritts auf diesem Gebiet entsprechen die angegebenen Beispiele den
häufigsten Anwendungen zum Zeitpunkt der Erarbeitung dieser Internationalen Norm.
Microbiologie des aliments - Réaction de polymérisation en chaîne (PCR) pour la détection et la quantification des micro-organismes pathogènes dans les aliments - Caractéristiques de performance (ISO 22118:2011)
L'ISO 22118:2010 spécifie les exigences minimales relatives aux caractéristiques de performance pour la détection de séquences d'acide nucléique (ADN ou ARN) par méthodes moléculaires. L'ISO 22118:2010 s'applique à la détection de micro-organismes pathogènes présents dans les aliments et les extraits obtenus à partir de ces aliments en employant des méthodes de détection moléculaires fondées sur la réaction de polymérisation en chaîne (PCR).
L'ISO 22118:2010 peut également être utilisée, par exemple, pour la détection de micro-organismes pathogènes d'origine alimentaire dans des prélèvements environnementaux ainsi que dans les aliments pour animaux.
Mikrobiologija živil in krme - Odkrivanje prisotnosti in kvantifikacija patogenih mikroorganizmov v živilih s polimerazno verižno reakcijo (PCR) - Izvedbena merila (ISO 22118:2011)
Ta mednarodni standard opredeljuje minimalne zahteve za izvedbena merila za odkrivanje prisotnosti zaporedij nukleinskih kislin (DNK ali RNK) z molekularnimi metodami. Ta mednarodni standard se uporablja za odkrivanje prisotnosti patogenih mikroorganizmov v živilih in izolatih, pridobljenih iz njih, z uporabo molekularnih metod odkrivanja prisotnosti, ki temeljijo na polimerazni verižni reakciji (PRC). Ta mednarodni standard se uporablja tudi za odkrivanje na primer prisotnosti patogenih mikroorganizmov v živilih v okoljskih vzorcih in krmah.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2011
Mikrobiologija živil in krme - Odkrivanje prisotnosti in kvantifikacija patogenih
mikroorganizmov v živilih s polimerazno verižno reakcijo (PCR) - Izvedbena merila
(ISO 22118:2011)
Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the
detection and quantification of food-borne pathogens - Performance characteristics (ISO
22118:2011)
Mikrobiologie von Lebensmitteln und Futtermitteln - Polymerase-Kettenreaktion (PCR)
zum Nachweis und zur quantitativen Bestimmung von pathogenen Mikroorganismen in
Lebensmitteln - Leistungsmerkmale (ISO 22118:2011)
Microbiologie des aliments - Réaction de polymérisation en chaîne (PCR) pour la
détection et la quantification des micro-organismes pathogènes dans les aliments -
Caractéristiques de performance (ISO 22118:2011)
Ta slovenski standard je istoveten z: EN ISO 22118:2011
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 22118
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2011
ICS 07.100.30
English Version
Microbiology of food and animal feeding stuffs - Polymerase
chain reaction (PCR) for the detection and quantification of food-
borne pathogens - Performance characteristics (ISO
22118:2011)
Microbiologie des aliments - Réaction de polymérisation en Mikrobiologie von Lebensmitteln und Futtermitteln -
chaîne (PCR) pour la détection et la quantification des
Polymerase-Kettenreaktion (PCR) zum Nachweis und zur
micro-organismes pathogènes dans les aliments - quantitativen Bestimmung von pathogenen
Caractéristiques de performance (ISO 22118:2011) Mikroorganismen in Lebensmitteln - Leistungsmerkmale
(ISO 22118:2011)
This European Standard was approved by CEN on 14 July 2011.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22118:2011: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 22118:2011) has been prepared by Technical Committee CEN/TC 275 “Food
analysis - Horizontal methods”, the secretariat of which is held by DIN, in collaboration with Technical
Committee ISO/TC 34 “Food products”.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by January 2012, and conflicting national standards shall be withdrawn at
the latest by January 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
INTERNATIONAL ISO
STANDARD 22118
First edition
2011-07-15
Microbiology of food and animal feeding
stuffs — Polymerase chain reaction
(PCR) for the detection and quantification
of food-borne pathogens — Performance
characteristics
Microbiologie des aliments — Réaction de polymérisation en chaîne
(PCR) pour la détection et la quantification des micro-organismes
pathogènes dans les aliments — Caractéristiques de performance
Reference number
ISO 22118:2011(E)
©
ISO 2011
ISO 22118:2011(E)
© ISO 2011
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ii © ISO 2011 – All rights reserved
ISO 22118:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 22118 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 275, Food analysis — Horizontal methods, in collaboration with Technical Committee ISO/TC 34,
Food products, Subcommittee SC 9, Microbiology, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
ISO 22118:2011(E)
Introduction
Molecular detection methods have been developed during the last few decades, and are now available for the
majority of food-borne pathogens. Some of these methods have the potential for quantitative analysis.
Although until now most methods have been based on the polymerase chain reaction (PCR) and real-time
PCR, other molecular detection and quantification principles should be kept under consideration.
To compare molecular methods with conventional methods or with other principles, it is necessary to generate
minimum requirements for performance characteristics of the methods to be developed.
This International Standard is part of a series of documents under the general title Microbiology of food and
animal feeding stuffs — Polymerase chain reaction (PCR) for the detection of food-borne pathogens:
ISO/TS 20836, Microbiology of food and animal feeding stuffs — Polymerase chain reaction (PCR) for the
detection of food-borne pathogens — Performance testing for thermal cyclers
ISO 20837, Microbiology of food and animal feeding stuffs — Polymerase chain reaction (PCR) for the
detection of food-borne pathogens — Requirements for sample preparation for qualitative detection
ISO 20838, Microbiology of food and animal feeding stuffs — Polymerase chain reaction (PCR) for the
detection of food-borne pathogens — Requirements for amplification and detection for qualitative methods
ISO 22118, Microbiology of food and animal feeding stuffs — Polymerase chain reaction (PCR) for the
detection and quantification of food-borne pathogens — Performance characteristics
ISO 22119, Microbiology of food and animal feeding stuffs — Real-time polymerase chain reaction (PCR) for
the detection of food-borne pathogens — General requirements and definitions
ISO 22174, Microbiology of food and animal feeding stuffs — Polymerase chain reaction (PCR) for the
detection of food-borne pathogens — General requirements and definitions
The following Technical Specification is in preparation:
ISO/TS 13136, Microbiology of food and animal feeding stuffs — Horizontal method for the detection of Shiga
toxin-producing Escherichia coli (STEC) belonging to O157, O111, O26, O103 and O145 serogroups —
Qualitative real-time polymerase chain reaction (PCR)-based method
iv © ISO 2011 – All rights reserved
INTERNATIONAL STANDARD ISO 22118:2011(E)
Microbiology of food and animal feeding stuffs — Polymerase
chain reaction (PCR) for the detection and quantification of
food-borne pathogens — Performance characteristics
1 Scope
This International Standard specifies minimum requirements of performance characteristics for the detection
of nucleic acid sequences (DNA or RNA) by molecular methods. This International Standard applies to the
detection of food-borne pathogens in foodstuffs and isolates obtained from them using molecular detection
methods based on the polymerase chain reaction (PCR).
This International Standard is also applicable, for example, to the detection of food-borne pathogens in
environmental samples and in animal feeding stuffs.
NOTE Because of the rapid progress in this field, the examples given are those most frequently in use at the time of
development of this International Standard.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 16140:2003, Microbiology of food and animal feeding stuffs — Protocol for the validation of alternative
methods
ISO 22174:2005, Microbiology of food and animal feeding stuffs — Polymerase chain reaction (PCR) for the
detection of food-borne pathogens — General requirements and definitions
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
analyte
component detected or measured by the method of analysis
NOTE 1 The analyte can be a microorganism or virus, its components or products.
NOTE 2 Adapted from ISO 16140:2003, 3.4.
3.2
qualitative method
method of analysis whose response is either the presence or absence of the analyte detected either directly or
indirectly in a certain amount of sample
[ISO 16140:2003, 3.5.]
ISO 22118:2011(E)
3.3
quantitative method
method of analysis whose response is the amount of the analyte measured either directly or indirectly in a
certain amount of sample
NOTE Adapted from ISO 16140:2003, 3.6.
3.4
robustness testing
〈food microbiology〉 subjecting the proposed method to small procedural changes or environmental factors to
determine what influence, if any, they have on method performance
3.5
selectivity
〈food microbiology〉 measure of the inclusivity (detection of the target microorganism or virus) and exclusivity
(non-detection of non-target microorganisms or viruses)
3.6
sensitivity
〈food microbiology〉 measure of the lowest number of analyte cells, particles or molecules which can be
detected in a single reaction
3.7
specificity
capacity to exclusively recognize the target to be detected, distinguishing it from similar substances and
impurities
[ISO 22174:2005, 3.6.4]
3.8
trueness
closeness of agreement between the expectation of a test result or a measurement result and a true value
[1]
[ISO 3534-2:2006 , 3.3.3]
3.9
detection limit
limit of detection
LOD
lowest concentration or content of the target organism relative to the defined amount of matrix that can be
consistently detected under the experimental conditions specified in the method
NOTE Adapted from ISO 22174:2005, 3.1.8.
3.10
quantification limit
limit of quantification
LOQ
〈food microbiology〉 smallest amount of analyte (that is the lowest actual number of organisms), which can be
measured and quantified with defined trueness and precision under the experimental conditions by the
method under validation
NOTE Adapted from ISO 16140:2003, 6.2.2.2.3.
3.11
precision
closeness of agreement between independent test/measurement results obtained under stipulated conditions
2 © ISO 2011 – All rights reserved
ISO 22118:2011(E)
NOTE 1 Precision depends only on the distribution of random errors and does not relate to the true value or the
specified value.
NOTE 2 The measure of precision is usually expressed in terms of imprecision and computed as a standard deviation
of the test results or
...
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